Culturally Adapting CBT for East Asian Youth in Ontario

• ClinicalTrials.gov Identifier: NCT03711344
• Recruitment Status: Unknown
• First Posted: October 18, 2018
• Last Update Posted: February 1, 2019
• Sponsor: Centre for Addiction and Mental Health
• Collaborators: East Metro Youth Services; Hong Fook Mental Health Association; Ontario Centre of Excellence for Child and Youth Mental Health
• Information provided by (Responsible Party): Centre for Addiction and Mental Health

Study Description

Brief Summary:

This mixed methods study proposes a culturally adapted cognitive behavioural therapy (CA-CBT) model for an East Asian demographic in Canada. The client population of East Asian youth who have been diagnosed with anxiety and/or depression are the focus of the study. CBT has been proven as a very effective form of therapy, and when adapted can promote positive mental health outcomes for a growing and increasingly vulnerable population. Developing a culturally adapted version of CBT (CA-CBT) for this population adds a practical treatment that improves access to culturally relevant care.

Condition or disease	Intervention/treatment	Phase
Anxiety; Depression	Behavioral: Cognitive Behavioral Therapy	Not Applicable

Detailed Description:

There is a major lack of culturally relevant mental health services for East Asian youth in Ontario and Canada. Beginning with a participatory/qualitative research approach, common themes amongst clients, caregivers, healthcare professionals, and community leaders, will divulge basic elements needed to develop a culturally adapted model of cognitive behavioural therapy. The information from the adapted model will be taught to participating psychologists who will deliver the therapy in a randomized control trial design, with feasibility testing of the intervention using a quantitative approach ensuing. Immediate guidelines will then be developed for use by therapists working with East Asian youth.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: East Asian youth diagnosed with Anxiety and/or depression will be randomly assigned to either the experimental group (receives the cultural adapted version of cognitive behavioral therapy) or the control group (non-culturally adapted cognitive behavioral therapy). It is a randomized control trial design.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Access to High Quality, Culturally Relevant Treatment for East Asian Canadian Youth in Ontario
• Actual Study Start Date: January 4, 2019
• Estimated Primary Completion Date: September 18, 2019
• Estimated Study Completion Date: September 18, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Culturally adapted Cognitive Behavioral therapy; The experimental group will receive the culturally adapted version of cognitive behavioral therapy.	Behavioral: Cognitive Behavioral Therapy; The intervention will be administered by therapists working at community agencies who are experienced at providing Cognitive Behavioral Therapy.
Active Comparator: Non-adapted Cognitive Behavioral therapy; The control group will receive the original (non-adapted) version of cognitive behavioral therapy.	Behavioral: Cognitive Behavioral Therapy; The intervention will be administered by therapists working at community agencies who are experienced at providing Cognitive Behavioral Therapy.

Outcome Measures

Primary Outcome Measures :

1. Severity levels of depression and anxiety rated by the Hospital Anxiety and Depression Scale (HADS). [ Time Frame: 4 months. ]
   Severity levels of depression and anxiety will be rated pre- and post-intervention by the Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0 to 21 for anxiety and 0 to 21 for depression. A score of 0 to 7 for depression and/or anxiety is considered a normal range. A score of 8 to 10 suggests the potential presence of depression and/or anxiety. A score of 11 or more suggests a likely presence of depression and/or anxiety.
2. Severity levels of depression and anxiety rated by the Bradford Somatic Inventory (BSI). [ Time Frame: 4 months. ]
   Severity levels of depression and anxiety will be rated pre- and post-intervention by the Bradford Somatic Inventory (BSI). The Bradford Somatic Inventory uses "yes" or "no" questions relating to somatic symptoms of anxiety and/or depression. A "yes" response to a question equates to a somatic symptom linked to depression and/or anxiety. The maximum number of "yes" responses is 46 and the minimum is 0. A higher number of "yes" responses suggests a potential increase in the severity of depression and/or anxiety.

Secondary Outcome Measures :

1. Satisfaction of the culturally adapted Cognitive Behavioral Therapy assessed using the Verona Satisfaction Scale. [ Time Frame: 4 months. ]
   Satisfaction will be measured using the Verona Satisfaction Scale. This scale measures patients satisfaction with health care services. The items are rated by 4 categories labelled: "strongly disagree", "disagree", "agree", and "strongly agree", on a scale of 1 to 4. A higher sub-scale/domain score indicates better satisfaction. All sub-scales are summed up to compute total/domain score. This scale will be used to identify the strengths and weaknesses of the therapy service and provide guidance for further development.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Self identification as East Asian origin
• Between the ages of 12 to 21
• Diagnosed as having depression and/or anxiety

Exclusion Criteria:

• Have been affected by psychosis
• Have been affected by serious addiction
• Have been affected by cognitive impairment

Contacts and Locations

Contacts

Contact: Myra Levy; 416-438-3697 ext 12243; mlevy@emys.on.ca

Contact: Sireesha Bobbili, MPH; 416-535-8501 ext 36573; Sireesha.Bobbili@camh.ca

Locations

Canada, Ontario

East Metro Youth Services; Recruiting

Scarborough, Ontario, Canada, M1H 3C3

Contact: Myra Levy 4164383697 ext 12243 mlevy@emys.on.ca

Contact: Arlene GonashNelson agonashnelson@emys.on.ca

Principal Investigator: Farooq Naeem, PhD/MD

Sponsors and Collaborators

Centre for Addiction and Mental Health

East Metro Youth Services

Hong Fook Mental Health Association

Ontario Centre of Excellence for Child and Youth Mental Health

Investigators

• Principal Investigator: Farooq Naeem, M.D.; Centre for Addiction and Mental Health
• Study Director: Myra Levy, M.A.; East Metro Youth Services

More Information

• Responsible Party: Centre for Addiction and Mental Health
• ClinicalTrials.gov Identifier: NCT03711344
• Other Study ID Numbers: innovation-1927
• First Posted: October 18, 2018
• Last Update Posted: February 1, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre for Addiction and Mental Health:

Cognitive Behavioral Therapy; Cultural Adaptation; East Asian Youth

Additional relevant MeSH terms:

Depression; Behavioral Symptoms